Director / Senior Director, Quality

Character Biosciences

25d•$200,000 - $270,000

About The Position

Character Biosciences is seeking a hands-on, execution-focused quality leader to build and own its GxP quality system as the company moves into Phase 2. The role owns clinical quality (GCP) and CMC quality (GMP), including procedures, the Qualio quality management system, vendor qualification and oversight, training, audits, and inspection readiness. The system should be fit for a company of approximately fifty people. The position is based in Brisbane, California; Jersey City, New Jersey; or remotely, and reports to the CSO in Brisbane. The role leads the clinical quality management system, including document control, procedure lifecycle, training, deviations, CAPA, quality issue escalation, and periodic review. It maintains a proportionate procedure set; administers Qualio; establishes risk-based vendor oversight; directs quality risk management; owns GCP and role-based training; manages sponsor audits and regulatory inspections; oversees vendor quality events; and runs a risk-scoped audit program. It also serves as the GCP quality interface and subject matter expert for functional teams and leadership. For CMC quality, the role owns the GMP quality system in the same Qualio instance and oversees qualification and audits of relevant manufacturing, testing, packaging, depot, and distribution vendors. Responsibilities include quality oversight of manufacturing campaigns, including person-in-plant presence for critical operations and batch record review; cold-chain distribution practices; and product complaint, investigation, recall, and periodic product quality review procedures as applicable. The successful candidate applies deep GxP judgment proportionately and is willing to perform hands-on quality work, including reviewing batch records, configuring a QMS, preparing vendor oversight plans, and participating in CRO governance. The role requires accountability for quality decisions and collaboration across the company in support of regulated work and patient safety.

Requirements

Bachelor’s degree in a life science or related field.
At least ten years of GxP quality assurance experience in biotechnology or biopharmaceuticals.
For the Senior Director level, three or more years at Director level or equivalent accountability.
Hands-on clinical quality experience for interventional trials, including vendor qualification, deviation and CAPA management, and inspection.
Hands-on GMP quality experience, including personal review and disposition of executed batch records, temperature excursion assessments, CDMO/CRO audits, and person-in-plant work; oversight of others performing this work is insufficient.
Ownership of an electronic quality management system as administrator or process owner, including configuration, document control, training curricula and assignment, periodic review, and change control.
Demonstrated experience retiring or consolidating procedures and defending those decisions to an auditor.
Working command of ICH E6(R3), ICH Q9 and Q10, and 21 CFR Parts 11, 210, 211, and 312.
Experience serving as the quality function at a company with fewer than roughly one hundred people and no quality department beneath them.
Willingness to provide the accountable quality signature and uphold quality decisions with executives, vendors, and investigators.
Applicants must be authorized to work in the United States.

Nice To Haves

Sponsor-side experience with global trials.
Qualio administrator experience specifically.
Experience hosting or supporting a sponsor inspection, such as FDA BIMO, EMA, or MHRA, and managing the resulting findings.
Computerized system validation and Part 11 compliance experience for clinical systems, including EDC, IRT, eTMF, and imaging or reading-center platforms.
Experience taking a company from Phase 2 into Phase 3 or registrational work.
GLP oversight of nonclinical programs.
Open, positive, and collaborative approach.

Responsibilities

Own the clinical quality management system, including document control, procedure lifecycle, training, deviations, CAPA, quality issue escalation, and periodic review.
Author, revise, consolidate, and retire SOPs through a controlled document lifecycle, with documented rationale, process-owner agreement, and quality approval.
Serve as Qualio administrator and process owner, managing configuration, workflows, document control, training curricula and assignment, periodic review cycles, change control, and system reporting.
Establish and implement a risk-based GxP vendor qualification and oversight framework, including qualification criteria, initial and periodic assessments, performance monitoring, qualification records, and quality agreements.
Apply risk-based quality management by identifying critical-to-quality factors, documenting protocol-specific quality risk assessments, and directing oversight toward patient and data-integrity risks.
Own GCP and role-based training curricula, assignment, completion, and competency tracking across the company.
Manage sponsor audits and regulatory inspections, and drive responses and CAPA to closure.
Oversee vendor quality-event reporting and trending, including reporting requirements, timelines, metrics, CAPA integration, ownership, and closure tracking.
Run a risk-scoped audit program covering vendors, investigator sites, and internal processes.
Serve as the quality interface with functional owners and as the GCP subject matter expert on protocol design, study conduct, and regulatory expectations; surface risks and trends and partner on study planning and decisions.
Own the GMP quality system in the shared Qualio instance, including document control, deviations, change control, CAPA, and training under common governance.
Qualify and audit contract manufacturers, substance CDMOs, fill-finish operations, testing laboratories, labelling and packaging suppliers, and depot and distribution networks as needed.
Provide quality oversight of manufacturing campaigns, including person-in-plant presence for critical operations, on-site batch record review, and real-time deviation decisions when needed.
Maintain good distribution practice for cold-chain clinical supply, including shipping qualification, temperature monitoring, excursion disposition, and depot oversight.
Own product complaint, investigation, and recall procedures for clinical supply, and periodic product quality review as applicable.